A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

Kissei

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Tolterodine; Drug: Placebo; Drug: KUC-7483

Study type: Interventional

Funder types: Industry

Identifiers

NCT01004315

KUC1301

Details and patient eligibility

About

To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.

Enrollment: 750 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a symptom of overactive bladder for more than 6 months.

• Patients who meet the following condition during the 3-day bladder diary period.

  • the mean number of micturitions per 24 hours is ≥8 times
  • the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion criteria

• Patients who are diagnosed as stress urinary incontinence are predominant.
• Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 3 patient groups, including a placebo group

KUC-7483

Experimental group

Treatment:

Drug: KUC-7483

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Tolterodine

Active Comparator group

Treatment:

Drug: Tolterodine